Rocuronium 10 mg/mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Nondepolarizing Neuromuscular Blocker class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Rocuronium is a muscle relaxant your anesthesia team uses to temporarily relax all your muscles — including the ones that control your airway — so they can safely place a breathing...
- Why am I being given rocuronium? What does it actually do?
- No — rocuronium has no effect on consciousness or your ability to feel pain. It only relaxes your muscles. Your anesthesia team will always give you anesthesia or sedation alongsid...
- Will I be awake or feel anything while it's working?
Patient education
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rocuronium 10 mg/mL 65219-0065-05 | Fresenius | 10 vials | $0.394 | AP | Availability likely | — |
| rocuronium bromide 10 mg/mL 00409-1403-10 | Hospira, | 10 vials | $0.394 | AP | Availability likely | — |
| rocuronium bromide 10 mg/mL 00409-3189-10 | Hospira, | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium Bromide 10 mg/mL 25021-0687-05 | Sagent | 10 vials | $0.394 | AP | Availability likely | — |
| rocuronium bromide 10 mg/mL 39822-4200-02 | XGen | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium 10 mg/mL 63323-0426-05 | Fresenius | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium Bromide 10 mg/mL 71288-0700-06 | Meitheal | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium Bromide 10 mg/mL 71839-0141-10 | BE | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium Bromide 10 mg/mL 72572-0650-10 | Civica, | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium Bromide 10 mg/mL 67457-0228-05 | Mylan | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium 10 mg/mL 65219-0442-05 | Fresenius | 10 vials | $0.394 | — | Availability likely | — |
| Rocuronium 10 mg/mL 81565-0204-02 | Phlow | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium Bromide 10 mg/mL 00409-9558-49 | Hospira, | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium Bromide 10 mg/mL 00143-9250-10 | Hikma | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium Bromide 10 mg/mL 65145-0130-10 | Caplin | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium 10 mg/mL 65219-0695-05 | Fresenius | 10 vials | $0.394 | — | Availability likely | — |
| Rocuronium 10 mg/mLthis 65219-0444-10 | Fresenius | 10 vials | — | — | FDA listed | — |
| Rocuronium 10 mg/mL 65219-0697-10 | Fresenius | 10 vials | — | — | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 00781-3220-92 | Sandoz | 10 vials | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 51662-1355-01 | HF | 10 ml | — | AP | FDA listed | — |
| rocuronium bromide 10 mg/mL 00409-5160-10 | Hospira, | 10 vials | — | AP | FDA listed | — |
| rocuronium bromide 10 mg/mL 00409-7037-10 | Hospira, | 10 vials | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 71288-0718-11 | Meitheal | 10 vials | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 71839-0142-10 | BE | 10 vials | — | AP | FDA listed | — |
| rocuronium bromide 10 mg/mL 71872-7036-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 71872-7207-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 51662-1640-01 | HF | 5 ml | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 71872-7317-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 72572-0651-10 | Civica, | 10 vials | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 68083-0365-10 | Gland | 10 vials | — | AP | FDA listed | — |
| rocuronium bromide 10 mg/mL 71872-7309-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 51662-1354-01 | HF | 5 ml | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 71872-7344-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 84549-0131-10 | ProPharma | 10 ml | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 84549-0141-10 | ProPharma | 5 ml | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 71872-7372-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 65145-0131-10 | Caplin | 10 vials | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 51662-1641-01 | HF | 10 ml | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 00143-9251-10 | Hikma | 10 vials | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 68083-0364-10 | Gland | 10 vials | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 84549-0687-05 | ProPharma | 5 ml | — | AP | FDA listed | — |
| Rocuronium 10 mg/mL 76045-0221-50 | Fresenius | 10 syringes | — | — | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 51662-1710-01 | HF | 10 ml | — | AP | FDA listed | — |
| Rocuronium Bromide 10 mg/mL 51662-1711-01 | HF | 5 ml | — | AP | FDA listed | — |
| Rocuronium 10 mg/mL 76045-0220-50 | Fresenius | 10 syringes | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65219-0444-10 You're viewing this | 10 VIAL in 1 TRAY (65219-444-10) / 10 mL in 1 VIAL (65219-444-04) | 2023-10-11 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Rocuronium Bromide Injection is indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Rocuronium Bromide Injection should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. ( 2.1 ) Individualize the dose for each patient. ( 2.1 ) Peripheral nerve stimulator recommended for determination of drug response and need for additional doses, and to evaluate recovery.
( 2.1 ) Store Rocuronium Bromide Injection with cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product. ( 2.1 ) Tracheal intubation : Recommended initial dose is 0.6 mg/kg. ( 2.2 ) Rapid sequence intubation : 0.6 to 1.2 mg/kg.
( 2.3 ) Maintenance doses : Guided by response to prior dose, not administered until recovery is evident. ( 2.4 ) Continuous infusion : Initial rate of 10 to 12 mcg/kg/min. Start only after early evidence of spontaneous recovery from an intubating dose.
( 2.5 )
2.1Important Dosing and Administration Information Rocuronium Bromide Injection is for intravenous use only. Rocuronium Bromide Injection should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. Doses of Rocuronium Bromide Injection should be individualized and a peripheral nerve stimulator should be used to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.
The dosage information which follows is derived from studies based upon units of drug per unit of body weight. It is intended to serve as an initial guide to clinicians familiar with other neuromuscular blocking agents to acquire experience with Rocuronium Bromide Injection. In patients in whom potentiation of, or resistance to, neuromuscular block is anticipated, a dose adjustment should be considered [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.10 , 5.13 ), Drug Interactions ( 7.2 , 7.3 , 7.4 , 7.5 , 7.6 , 7.8 , 7.10 ), Use in Specific Populations ( 8.6 )] .
Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal. Store Rocuronium Bromide Injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions ( 5.3 )] .
2.2Dose for Tracheal Intubation The recommended initial dose of Rocuronium Bromide Injection, regardless of anesthetic technique, is 0.6 mg/kg. Neuromuscular block sufficient for intubation (80% block or greater) is attained in a median (range) time of 1 (0.4-6) minute(s) and most patients have intubation completed within 2 minutes. Maximum blockade is achieved in most patients in less than 3 minutes.
This dose may be expected to provide 31 (15-85) minutes of clinical relaxation under opioid/nitrous oxide/oxygen anesthesia. Under halothane, isoflurane, and enflurane anesthesia, some extension of the period of clinical relaxation should be expected [see Drug Interactions ( 7.3 )] . A lower dose of Rocuronium Bromide Injection (0.45 mg/kg) may be used.
Neuromuscular block sufficient for intubation (80% block or greater) is attained in a median (range) time of 1.3 (0.8-6.2) minute(s), and most patients have intubation completed within 2 minutes. Maximum blockade is achieved in most patients in less than 4 minutes. This dose may be expected to provide 22 (12-31) minutes of clinical relaxation under opioid/nitrous oxide/oxygen anesthesia.
Patients receiving this low dose of 0.45 mg/kg who achieve less than 90% block (about 16% of these patients) may have a more rapid time to 25% recovery, 12 to 15 minutes. A large bolus dose of 0.9 or 1.2 mg/kg can be administered under opioid/nitrous oxide/oxygen anesthesia without adverse effects to the cardiovascular…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Rocuronium Bromide Injection is a clear, colorless to yellow/orange solution, free from visible particulate matter available as: 50 mg/5 mL (10 mg/mL), single-dose vials 100 mg/10 mL (10 mg per mL), single-dose vials 50 mg/5 mL (10 mg/mL). ( 3 ) 100 mg/10 mL (10 mg/mL). ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Rocuronium Bromide Injection is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see Warnings and Precautions ( 5.2 )] . Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Appropriate Administration and Monitorin g: Use only if facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available. ( 5.1 ) Anaphylaxis : Severe anaphylaxis has been reported. Consider cross-reactivity among neuromuscular blocking agents.
( 5.2 ) Risk of Death due to Medication Errors : Accidental administration can cause death. ( 5.3 ) Need for Adequate Anesthesia : Must be accompanied by adequate anesthesia or sedation. ( 5.4 ) Residual Paralysis : Consider using a reversal agent in cases where residual paralysis is more likely to occur.
( 5.5 )
5.1Appropriate Administration and Monitoring Rocuronium Bromide Injection should be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are familiar with the drug's actions and the possible complications of its use. Rocuronium Bromide Injection should not be administered unless facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available. It is recommended that clinicians administering neuromuscular blocking agents such as Rocuronium Bromide Injection employ a peripheral nerve stimulator to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.
5.2Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including Rocuronium Bromide Injection, have been reported. These reactions have, in some cases (including cases with Rocuronium Bromide Injection), been life threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken.
Precautions should also be taken in those patients who have had previous anaphylactic reactions to other neuromuscular blocking agents, since cross-reactivity between neuromuscular blocking agents, both depolarizing and nondepolarizing, has been reported.
5.3Risk of Death due to Medication Errors Administration of Rocuronium Bromide Injection results in paralysis, which may lead to respiratory arrest and death, a progression that may be more likely to occur in a patient for whom it is not intended. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. If another healthcare provider is administering Rocuronium Bromide Injection, ensure that the intended dose is clearly labeled and communicated.
5.4Need for Adequate Anesthesia Rocuronium Bromide Injection has no known effect on consciousness, pain threshold, or cerebration. Therefore, its administration must be accompanied by adequate anesthesia or sedation.
5.5Residual Paralysis To prevent complications resulting from residual paralysis from Rocuronium Bromide Injection, it is recommended to extubate only after the patient has recovered sufficiently from neuromuscular block. Geriatric patients (65 years or older) may be at increased risk for residual neuromuscular block. Other factors which could cause residual paralysis after extubation in the post- operative phase (such as drug interactions or patient condition) should also be considered.
If not used as part of standard clinical practice the use of a reversal agent should be considered, especially in those cases where residual paralysis is more likely to occur.
5.6Long-Term Use in an Intensive Care Unit Rocuronium Bromide Injection has not been studied for long-term use in the intensive care unit (ICU). As with other nondepolarizing neuromuscular blocking drugs, apparent tolerance to Rocuronium Bromide Injection may develop during chronic administration in the ICU. While the mechanism for development of this resistance is not known, receptor up-regulation may be a contributing factor.
It is strongly recommended that…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension. The following adverse reactions are described, or described in greater detail, in other sections: Anaphylaxis [see Warnings and Precautions ( 5.2 )] Residual paralysis [see Warnings and Precautions ( 5.5 )] Myopathy [see Warnings and Precautions ( 5.6 )] Increased pulmonary vascular resistance [see Warnings and Precautions ( 5.12 )] Most common adverse reactions (2%) are transient hypotension and hypertension.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical studies of another rocuronium bromide injection product in the U.S. (n=1137) and Europe (n=1394) totaled 2531 patients.
The following adverse reactions were reported in patients administered another rocuronium bromide injection (all events judged by investigators during the clinical trials to have a possible causal relationship): Adverse reactions in greater than 1% of patients: None Adverse reactions in less than 1% of patients (probably related or relationship unknown): Cardiovascular: arrhythmia, abnormal electrocardiogram, tachycardia Digestive: nausea, vomiting Respiratory: asthma (bronchospasm, wheezing, or rhonchi), hiccup Skin and Appendages: rash, injection site edema, pruritus In the European studies of another rocuronium bromide injection product, the most commonly reported reactions were transient hypotension (2%) and hypertension (2%); these are in greater frequency than the US studies (0.1% and 0.1%).
Changes in heart rate and blood pressure were defined differently from in the US studies in which changes in cardiovascular parameters were not considered as adverse events unless judged by the investigator as unexpected, clinically significant, or thought to be histamine related. In a clinical study of another rocuronium bromide injection product in patients with clinically significant cardiovascular disease undergoing coronary artery bypass graft, hypertension and tachycardia were reported in some patients, but these occurrences were less frequent in patients receiving beta or calcium channel-blocking drugs.
In some patients, the use of another rocuronium bromide injection product was associated with transient increases (30% or greater) in pulmonary vascular resistance. In another clinical study of patients undergoing abdominal aortic surgery, transient increases (30% or greater) in pulmonary vascular resistance were observed in about 24% of patients who received another rocuronium bromide injection product at 0.6 or 0.9 mg/kg. In pediatric patient studies worldwide of another rocuronium bromide injection product (n=704), tachycardia occurred at an incidence of 5.3% (n=37), and it was judged by the investigator as related in 10 cases (1.4%).
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of rocuronium bromide injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune system disorders: In clinical practice, there have been reports of severe allergic reactions (anaphylactic reactions and shock) with rocuronium bromide injection, including some that have been life-threatening and fatal [see Warnings and Precautions ( 5.2 )] .
General disorders and administration site conditions: There have been reports of malignant hyperthermia with the use of rocuronium bromide injection [see Warnings and Precautions ( 5.7 )].
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Succinylcholine : Use before succinylcholine has not been studied. ( 7.11 ) Nondepolarizing muscle relaxants : Interactions have been observed. ( 7.7 ) Enhanced Rocuronium Bromide Injection activity possible : Inhalation anesthetics ( 7.3 ), certain antibiotics ( 7.1 ), quinidine ( 7.10 ), magnesium ( 7.6 ), lithium ( 7.4 ), local anesthetics ( 7.5 ), procainamide ( 7.8 ) Reduced Rocuronium Bromide Injection activity possible : Anticonvulsants.
( 7.2 )
7.1Antibiotics Drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as Rocuronium Bromide Injection include certain antibiotics (e.g., aminoglycosides; vancomycin; tetracyclines; bacitracin; polymyxins; colistin; and sodium colistimethate). If these antibiotics are used in conjunction with Rocuronium Bromide Injection, prolongation of neuromuscular block may occur.
7.2Anticonvulsants In 2 of 4 patients who received chronic anticonvulsant therapy, apparent resistance to the effects of another rocuronium bromide injection product was observed in the form of diminished magnitude of neuromuscular block or shortened clinical duration. As with other nondepolarizing neuromuscular blocking drugs, if Rocuronium Bromide Injection is administered to patients chronically receiving anticonvulsant agents such as carbamazepine or phenytoin, shorter durations of neuromuscular block may occur and infusion rates may be higher due to the development of resistance to nondepolarizing muscle relaxants.
While the mechanism for development of this resistance is not known, receptor up-regulation may be a contributing factor [see Warnings and Precautions ( 5.10 )] .
7.3Inhalation Anesthetics Use of inhalation anesthetics (enflurane > isoflurane > halothane) has been shown to enhance the activity of other neuromuscular blocking agents. Isoflurane and enflurane may also prolong the duration of action of initial and maintenance doses of Rocuronium Bromide Injection and decrease the average infusion requirement of Rocuronium Bromide Injection by 40% compared to opioid/nitrous oxide/oxygen anesthesia. No definite interaction between rocuronium bromide injection and halothane has been demonstrated.
In one study, use of enflurane in 10 patients who received another rocuronium bromide injection product resulted in a 20% increase in mean clinical duration of the initial intubating dose, and a 37% increase in the duration of subsequent maintenance doses, when compared in the same study to 10 patients under opioid/nitrous oxide/oxygen anesthesia. The clinical duration of initial doses of another rocuronium bromide injection product (0.57 to 0.85 mg/kg) under enflurane or isoflurane anesthesia, as used clinically, was increased by 11% and 23%, respectively.
The duration of maintenance doses was affected to a greater extent, increasing by 30% to 50% under either enflurane or isoflurane anesthesia. Potentiation by these agents was also observed with respect to the infusion rates of rocuronium bromide injection required to maintain approximately 95% neuromuscular block. Under isoflurane and enflurane anesthesia, the infusion rates were decreased by approximately 40% compared to opioid/nitrous oxide/oxygen anesthesia.
The median spontaneous recovery time (from 25% to 75% of control T1) was not affected by halothane but is prolonged by enflurane (15% longer) and isoflurane (62% longer). Reversal-induced recovery of Rocuronium Bromide Injection neuromuscular block is minimally affected by anesthetic technique [see Dosage and Administration ( 2.6 ) and Warnings and Precautions ( 5.10 )] .
7.4Lithium Carbonate Lithium has been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see Warnings and Precautions ( 5.10 )] .
7.5Local Anesthetics Local anesthetics have been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see War…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy : Not recommended for rapid sequence induction in patients undergoing Cesarean section. ( 8.1 , 14.1 ) Pediatric Use : Onset time and duration will vary with dose, age, and anesthetic technique. Not recommended for rapid sequence intubation in pediatric patients. ( 8.4 )
8.1Pregnancy Risk Summary Available data from controlled trials and case series and over decades of use of rocuronium bromide in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are potential risks when rocuronium bromide is used during labor or delivery (see Clinical Considerations ). Based on data from umbilical cord blood sampling, rocuronium bromide is transferred across the placenta [see Clinical Studies ( 14.1 )] .
In animal reproduction studies, there was no evidence of teratogenicity when rocuronium bromide was administered intravenously to pregnant, conscious, nonventilated rats and rabbits at 15%-30% and 25%, respectively, the human intubation dose of 0.6-1.2 mg/kg during the period of organogenesis (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Labor or Delivery: Magnesium sulfate used in the management of pre-eclampsia or eclampsia in pregnancy may enhance neuromuscular blockade [see Warning and Precautions 5.10 ]. The use of another rocuronium bromide injection product in Cesarean section has been studied in a limited number of patients.
Adverse events in this study included low APGAR scores in neonates at 5 minutes and poor intubation conditions in some pregnant women who received rocuronium bromide [see Clinical Studies ( 14.1 )] . Rocuronium Bromide Injection is not recommended for rapid sequence induction in Cesarean section patients. Data Animal Data: Developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats.
Inhibition of neuromuscular function was the endpoint for high-dose selection. The maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats (0.3 mg/kg, 15%-30% of human intubation dose of 0.6-1.2 mg/kg based on the body surface unit of mg/m 2 ) from Day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from Day 6 to 18 of pregnancy. High-dose treatment caused acute symptoms of respiratory dysfunction due to the pharmacological activity of the drug.
Teratogenicity was not observed in these animal species. The incidence of late embryonic death was increased at the high dose in rats, most likely due to oxygen deficiency. Therefore, this finding probably has no relevance for humans because immediate mechanical ventilation of the intubated patient will effectively prevent embryo-fetal hypoxia.
8.2Lactation Risk Summary There are no available data on the presence of rocuronium bromide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for rocuronium bromide and any potential adverse effects on the breastfed child from rocuronium bromide or from the underlying maternal condition.
8.4Pediatric Use The use of another rocuronium bromide injection product has been studied in pediatric patients 3 months to 14 years of age under halothane anesthesia. Of the pediatric patients anesthetized with halothane who did not receive atropine for induction, about 80% experienced a transient increase (30% or greater) in heart rate after intubation. One of the 19 infants anesthetized with halothane and fentanyl…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from controlled trials and case series and over decades of use of rocuronium bromide in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are potential risks when rocuronium bromide is used during labor or delivery (see Clinical Considerations ). Based on data from umbilical cord blood sampling, rocuronium bromide is transferred across the placenta [see Clinical Studies ( 14.1 )] .
In animal reproduction studies, there was no evidence of teratogenicity when rocuronium bromide was administered intravenously to pregnant, conscious, nonventilated rats and rabbits at 15%-30% and 25%, respectively, the human intubation dose of 0.6-1.2 mg/kg during the period of organogenesis (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Labor or Delivery: Magnesium sulfate used in the management of pre-eclampsia or eclampsia in pregnancy may enhance neuromuscular blockade [see Warning and Precautions 5.10 ]. The use of another rocuronium bromide injection product in Cesarean section has been studied in a limited number of patients.
Adverse events in this study included low APGAR scores in neonates at 5 minutes and poor intubation conditions in some pregnant women who received rocuronium bromide [see Clinical Studies ( 14.1 )] . Rocuronium Bromide Injection is not recommended for rapid sequence induction in Cesarean section patients. Data Animal Data: Developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats.
Inhibition of neuromuscular function was the endpoint for high-dose selection. The maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats (0.3 mg/kg, 15%-30% of human intubation dose of 0.6-1.2 mg/kg based on the body surface unit of mg/m 2 ) from Day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from Day 6 to 18 of pregnancy. High-dose treatment caused acute symptoms of respiratory dysfunction due to the pharmacological activity of the drug.
Teratogenicity was not observed in these animal species. The incidence of late embryonic death was increased at the high dose in rats, most likely due to oxygen deficiency. Therefore, this finding probably has no relevance for humans because immediate mechanical ventilation of the intubated patient will effectively prevent embryo-fetal hypoxia.
🧒 Pediatric Use ▾
8.4Pediatric Use The use of another rocuronium bromide injection product has been studied in pediatric patients 3 months to 14 years of age under halothane anesthesia. Of the pediatric patients anesthetized with halothane who did not receive atropine for induction, about 80% experienced a transient increase (30% or greater) in heart rate after intubation. One of the 19 infants anesthetized with halothane and fentanyl who received atropine for induction experienced this magnitude of change [see Dosage and Administration ( 2.6 ), Clinical Studies ( 14.3 )] .
Another rocuronium bromide injection product was also studied in pediatric patients up to 17 years of age, including neonates, under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia. Onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique. The overall analysis of ECG data in pediatric patients indicated that the concomitant use of Rocuronium Bromide Injection with general anesthetic agents can prolong the QTc interval.
The data also suggest that Rocuronium Bromide Injection may increase heart rate. However, it was not possible to conclusively identify an effect of rocuronium bromide independent of that of anesthesia and other factors. Additionally, when examining plasma levels of rocuronium bromide in correlation to QTc interval prolongation, no relationship was observed [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.9 ), Clinical Studies ( 14.3 )].
Rocuronium Bromide Injection is not recommended for rapid sequence intubation in pediatric patients. Recommendations for use in pediatric patients are discussed in other sections of labeling [see Dosage and Administration ( 2.6 ) Clinical Pharmacology ( 12.2 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Another rocuronium bromide injection product was administered to 140 geriatric patients (65 years of age or older) in U.S. clinical trials and 128 geriatric patients in European clinical trials. The observed pharmacokinetic profile of rocuronium bromide for geriatric patients (n=20) was similar to that for other adult surgical patients [see Clinical Pharmacology ( 12.3 )] . However, onset time and duration of action of rocuronium bromide were slightly longer for geriatric patients (n=43) in clinical trials.
Clinical experiences and recommendations for use of Rocuronium Bromide Injection in geriatric patients are discussed in other sections of the labeling [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.2 ), Clinical Studies ( 14.2 )].
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage with neuromuscular blocking agents may result in neuromuscular block beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway, controlled ventilation, and adequate sedation until recovery of normal neuromuscular function is assured. Once evidence of recovery from neuromuscular block is observed, further recovery may be facilitated by administration of an anticholinesterase agent in conjunction with an appropriate anticholinergic agent.
Reversal of Neuromuscular Blockade: Anticholinesterase agents should not be administered prior to the demonstration of some spontaneous recovery from neuromuscular blockade. The use of a nerve stimulator to document recovery is recommended. Patients should be evaluated for adequate clinical evidence of neuromuscular recovery, e.g., 5-second head lift, adequate phonation, ventilation, and upper airway patency.
Ventilation must be supported while patients exhibit any signs of muscle weakness. Recovery may be delayed in the presence of debilitation, carcinomatosis, and concomitant use of certain drugs which enhance neuromuscular blockade or separately cause respiratory depression. Under such circumstances the management is the same as that of prolonged neuromuscular blockade.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. It acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium.
12.2Pharmacodynamics The Rocuronium Bromide Injection dose required to produce 95% suppression (ED95) of the first [T1] mechanomyographic [MMG] response of the adductor pollicis muscle [thumb] to indirect supramaximal train-of-four stimulation of the ulnar nerve) during opioid/nitrous oxide/oxygen anesthesia is approximately 0.3 mg/kg. Patient variability around the ED95 dose suggests that 50% of patients will exhibit T1 depression of 91% to 97%. Table 4 presents intubating conditions in patients with intubation initiated at 60 to 70 seconds.
Table 4: Percent of Excellent or Good Intubating Conditions and Median (Range) Time to Completion of Intubation in Patients with Intubation Initiated at 60 to 70 Seconds * Excludes patients undergoing Cesarean section. † Pediatric patients were under halothane anesthesia. Excellent intubating conditions=jaw relaxed, vocal cords apart and immobile, no diaphragmatic movement. Good intubating conditions=same as excellent but with some diaphragmatic movement. rocuronium bromide injection Dose (mg/kg) Administered Over 5 sec Percent of Patients with Excellent or Good Intubating Conditions Time to Completion of Intubation (min) Adults* 18 to 64 yrs 0.45 (n=43) 0.6 (n=51) 86% 96% 1.6 (1.0-7.0) 1.6 (1.0-3.2) Infants † 3 mo to 1 yr 0.6 (n=18) 100% 1.0 (1.0-1.5) Pediatric † 1 to 12 yrs 0.6 (n=12) 100% 1.0 (0.5-2.3) Table 5 presents the time to onset and clinical duration for the initial dose of Rocuronium Bromide Injection under opioid/nitrous oxide/oxygen anesthesia in adults and geriatric patients, and under halothane anesthesia in pediatric patients.
Table 5: Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose During Opioid/Nitrous Oxide/Oxygen Anesthesia (Adults) and Halothane Anesthesia (Pediatric Patients) n=the number of patients who had time to maximum block recorded. Clinical duration=time until return to 25% of control T 1 . Patients receiving doses of 0.45 mg/kg who achieved less than 90% block (16% of these patients) had about 12 to 15 minutes to 25% recovery. rocuronium bromide injection Dose (mg/kg) Administered Over 5 sec Time to ≥80% Block (min) Time to Maximum Block (min) Clinical Duration (min) Adults 18 to 64 yrs 1.3 (0.8-6.2) 3.0 (1.3-8.2) 22 (12-31) 0.45 (n=50) 0.6 (n=142) 1.0 (0.4-6.0) 1.8 (0.6-13.0) 31 (15-85) 0.9 (n=20) 1.1 (0.3-3.8) 1.4 (0.8-6.2) 58 (27-111) 1.2 (n=18) 0.7 (0.4-1.7) 1.0 (0.6-4.7) 67 (38-160) Geriatric ≥65 yrs 2.3 (1.0-8.3) 3.7 (1.3-11.3) 46 (22-73) 0.6 (n=31) 0.9 (n=5) 2.0 (1.0-3.0) 2.5 (1.2-5.0) 62 (49-75) 1.2 (n=7) 1.0 (0.8-3.5) 1.3 (1.2-4.7) 94 (64-138) Infants 3 mo to 1 yr 0.6 (n=17) 0.8 (n=9) — — 0.8 (0.3-3.0) 0.7 (0.5-0.8) 41 (24-68) 40 (27-70) Pediatric 1 to 12 yrs 0.6 (n=27) 0.8 (n=18) 0.8 (0.4-2.0) — 1.0 (0.5-3.3) 0.5 (0.3-1.0) 26 (17-39) 30 (17-56) Table 6 presents the time to onset and clinical duration for the initial dose of Rocuronium Bromide Injection (rocuronium bromide) Injection under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia in pediatric patients.
Table 6: Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose During Sevoflurane (induction) and Isoflurane/Nitrous Oxide (maintenance) Anesthesia (Pediatric Patients) n=the number of patients with the highest number of observations for time to maximum block or reappearance T 3 . rocuronium bromide injection Dose (mg/kg) Administered Over 5 sec Time to Maximum Block (min) Time to Reappearance T 3 (min) Neonates birth to <28 days 1.1 (0.6-2.2) 40.3 (32.5-62.6) 0.45 (n=5) 0.6 (n=10) 1.0 (0.2-2.1) 49.7 (16.6-119.0) 1 (n=6…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. It acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Rocuronium Bromide Injection is a clear, colorless to yellow/orange solution, free from visible particulate matter and available in single-dose vials in the following packaging configurations: Product Code Unit of Sale Strength Each 442105 NDC 65219-442-05 Unit of 10 50 mg per 5 mL (10 mg per mL) NDC 65219-442-02 Single-Dose Vial RF442105 NDC 65219-695-05 Unit of 10 50 mg per 5 mL (10 mg per mL) NDC 65219-695-01 Single-Dose Vial This product is RFID-enabled. 442110 NDC 65219-444-10 Unit of 10 100 mg per 10 mL (10 mg per mL) NDC 65219-444-04 Single-Dose Vial RF442110 NDC 65219-697-10 Unit of 10 100 mg per 10 mL (10 mg per mL) NDC 65219-697-01 Single-Dose Vial This product is RFID-enabled.
The container closure is not made with natural rubber latex. Rocuronium Bromide Injection should be stored at 20°C to 25°C (68°F to 77°F); Excursion permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.
Safety and Handling There is no specific work exposure limit for Rocuronium Bromide Injection. In case of eye contact, flush with water for at least 10 minutes. Single-Dose Vial.
Discard Unused Portion.
📋 Description ▾
11 DESCRIPTION Rocuronium bromide is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl) pyrrolidinium bromide. The structural formula is: Rocuronium bromide USP is an almost white to pale yellow, hygroscopic powder.
Rocuronium bromide is soluble in water and dichloromethane, slightly soluble in ethanol and methanol. The chemical formula is C 32 H 53 BrN 2 O 4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C.
Rocuronium Bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous use only. Each mL contains 10 mg rocuronium bromide (equivalent to 8.69 mg of rocuronium) and inactive ingredients 17.1 mcL hydrochloric acid, 8 mg sodium chloride. The solution pH is adjusted to 2.8 to 3.2 with hydrochloric acid and/or sodium hydroxide.
Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Obtain information about your patient's medical history, current medications, any history of hypersensitivity to rocuronium bromide or other neuromuscular blocking agents. If applicable, inform your patients that certain medical conditions and medications might influence how Rocuronium Bromide Injection works [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7 )] . In addition, inform your patient that severe anaphylactic reactions to neuromuscular blocking agents, including Rocuronium Bromide Injection, have been reported.
Because allergic cross-reactivity has been reported in this class, request information from your patients about previous anaphylactic reactions to other neuromuscular blocking agents [see Warnings and Precautions ( 5.2 )] . Manufactured by: www.fresenius-kabi.com/us 451851 Fresenius Kabi Logo